Medtronic Receives FDA Approval of New Guardian™ Continuous Glucose Monitoring System for Diabetes Management
- System is key component in diabetes technology pipeline. Device is designed to help alert patients to potentially dangerous fluctuations in blood sugar levels -
NORTHRIDGE, Calif., Feb. 11, 2004 - Medtronic, Inc. (NYSE: MDT), today announced U.S. Food and Drug Administration (FDA) approval of the Guardian™ Continuous Glucose Monitoring System, a device designed to protect diabetes patients by alerting them to potentially dangerous fluctuations in blood sugar (glucose) levels. By sounding an alarm when glucose levels become too high or too low, the system warns patients to take action to normalize their blood sugar, which can result in improved health and quality of life. Unhealthy blood sugar fluctuations can cause long-term complications, such as blindness, kidney failure, amputation, impotence and heart disease, as well as loss of consciousness or even death.
“Each year, thousands of children with nighttime hypoglycemia, or low blood sugar, and adults who are unaware that they have hypoglycemia, are at risk of serious complications and death due to having low blood sugar,” said Jeffery A. McCaulley, vice president and general manager of Medtronic’s Diabetes business. “For these patients and their families, the Guardian system represents a major improvement in the management of diabetes and peace of mind.”
Not only is the Guardian system an important ‘stand-alone’ tool for patient use, the system is an integral component in the company’s industry-leading diabetes technology pipeline. “We are making excellent progress on our near-term strategy of integrating Guardian sensor technology with a next-generation Paradigm® pump, as well as our longer-term strategy that includes the development of advanced algorithms to create an artificial pancreas,” said Scott Ward, senior vice president and president of Medtronic’s Neurological and Diabetes business. “Patients, however, need not wait for an artificial pancreas, as Medtronic’s insulin pump systems are optimal tools for diabetes care today.”
Approval of the Guardian system represents the latest in a series of technology advancements from Medtronic Diabetes, including the Paradigm 512 and 712 insulin pump systems and CGMS® System Gold™, a physician-use continuous glucose monitoring system. The company also recently introduced the industry’s first technology pathway program, allowing Paradigm pump users to remain at the forefront of technology advancements by upgrading to Medtronic’s integrated insulin pump systems as they become available.
The new Guardian system is an external device that utilizes a glucose sensor to continuously record blood sugar readings for up to three days. These glucose readings are transmitted to the monitor, which is designed to sound an alarm when blood sugar levels reach high or low limits pre-set by the patient or healthcare professional. Information from the system’s monitor can be downloaded to a computer for additional trend analysis to further improve diabetes care. The system requires a physician prescription and is calibrated a minimum of twice a day using a discrete blood glucose meter.
The Guardian system is well suited for any type 1 or type 2 diabetes patient who wishes to reduce erratic blood sugar fluctuations. The system is ideal for parents closely monitoring their children’s disease, patients who have lost their ability to detect rapid changes in blood sugar levels, and women with gestational diabetes or patients wishing to become pregnant. Diabetes patients whose mental sharpness is affected by rapidly changing glucose levels during work can also benefit from this important technology, as on-the-job accidents can affect their health and, potentially, the lives of others.
Approximately 18.2 million Americans are afflicted with diabetes, which continues to be the sixth-leading cause of death in the United States. Approximately 13 million people are diagnosed, while an estimated 5.2 million people remain undiagnosed. Another 20.1 million patients are estimated to have pre-diabetes, a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. In type 2 diabetes, the body is unable to make enough, or properly use, insulin. Type 1 diabetes occurs when the pancreas is unable to produce insulin.
Medtronic MiniMed (www.minimed.com), the Diabetes business of Medtronic, Inc., is the world leader in insulin pump therapy and continuous glucose monitoring systems. The company’s products include external insulin pumps, related disposable products, and continuous glucose monitoring systems for professional and patient use. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Additional information about the Guardian system is available online at www.minimed.com/guardianinfo. Information about the Paradigm 512 and 712 insulin pumps and the Paradigm Link blood glucose monitor is available online at www.minimed.com/paradigmlink.
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EDITOR’S NOTE: Detailed information about diabetes, insulin pump therapy and the Guardian system is available by accessing Medtronic’s online newsroom at www.medtronic.com/newsroom. Any statements made about the company’s anticipated regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company’s Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.
Contact:
Rachael Scherer, Investor Relations, 763-505-2694
Deanne McLaughlin, Public Relations, 818-576-4325 |
